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Quality Assurance Compliance Officer-HGCTP

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POST DATE 8/12/2016
END DATE 10/21/2016

University of California - Los Angeles Medical Centers Los Angeles, CA

Company
University of California - Los Angeles Medical Centers
Job Classification
Full Time
Company Ref #
H84407
Location
Los Angeles, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree
AJE Ref #
575862377

JOB DESCRIPTION

Job Title:
Quality Assurance Compliance Officer-HGCTP

UCLA Title:
Analyst, Administrative, Sr

Job No.:
H84407

Work Hours:
Monday-Friday

Work Location:
Westwood, CA.

Job Type:
Career

Duration:
Indefinite

Minimum Salary:
$26.29 / $4575

Maximum Salary:
$51.89 / $9029

Layoff Referral Deadline:
06/10/2016

Bargaining Unit:
99



JOB DUTIES:

Under the supervision of the Interim Associate Director and the Director of the Human Gene and Cell Therapy Program (HGCTP), the Quality Assurance Compliance Officer for the Human Gene and Cell Therapy Program (HGCTP) is responsible for 3 major functions within the HGCTP: Conduct monitoring and auditing of gene medicine clinical trials overseen by the HGCTP, the incumbent is responsible for the day-to-day GMP quality assurance compliance activities and the incumbent will manage Good Manufacturing Practices (GMP) Document control software.



JOB QUALIFICATIONS:

STRONGLY PREFFERED:

Bachelor of Science Degree in Biology, Chemistry, or related field and a minimum of 2 years of clinical trial monitoring, auditing or quality assurance experience, a Master's degree in science or healthcare discipline and one year of clinical trial monitoring, auditing or quality assurance experience or a higher degree (Ph.D. or Pharm D.) with knowledge about clinical trials.

REQUIRED:

Previous experience directly involved with federal regulations regarding GLP, GCP, GMP, HIPAA, etc. Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration & sponsors. Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables. Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions. Demonstrated skill in reviewing data and material compiled by others for completeness and accruacy to ensure that incorrect/incomplete data is corrected.

Ability to deal with and maintain confidential and sensitive information with discretion. Ability to determine what information is confidential and to protect the confidentiality of that information. Demonstrated skill in good decision making and taking appropriate action in situations where no established criteria exists or where answers to problems are not readily available. Ability to work on a diverse variety of projects simultaneously, organize multiple projects for efficiency and cost-effectiveness. Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work. On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences and investigator meetings. Strong oral and written communication skills. Exceptional database and computing skills. Excellent English-writing skills to compose, proofread correspondence and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation. Ability to write concise and accurate administrative reports, policies, procedures, and correspondence. Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel.

Demonstrated skill in records management. Skill in establishing and maintaining complex filing systems. Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports. Demonstrated skill in utilizing programs such as Word, Excel, and other database software. Ability to learn other systems/software as required. Demonstrated knowledge of FDA Good Clinical Practice, Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines. Demonstrated ability to develop and monitor quality improvement plans and SOPs. Teamwork skills as well as the ability to prioritize and demonstrate critical thinking. Demonstrated ability to work independently and collaboratively with multiple departments while utilizing innovation to elicit compliance.



Complete Application